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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, radioallergosorbent (rast) immunological
510(k) Number K200825
Device Name NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
Applicant
Hycor Biomedical
7272 Chapman Avenue
Garden Grove,  CA  92841
Applicant Contact Irene M. Guzman
Correspondent
Hycor Biomedical
7272 Chapman Avenue
Garden Grove,  CA  92841
Correspondent Contact Irene M. Guzman
Regulation Number866.5750
Classification Product Code
DHB  
Subsequent Product Code
JJE  
Date Received03/30/2020
Decision Date 06/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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